The present invention is directed to overcoming problems associated with traditional thin membrane rolled condoms in the fight against sexually transmitted diseases, including the spread of the human immunodeficiency virus (HIV) that can result in acquired immune deficiency syndrome (AIDS), while improving sexual sensation for the user.
Protection from sexually transmitted diseases is a public health concern that affects all people, regardless of sexual orientation, nationality and age group. Since the onset of AIDS in the early 1980s, the AIDS pandemic has particularly affected the gay community, with gay men comprising approximately two-thirds of all AIDS cases in the United States. However, an increasing number of heterosexual women and men have since become infected, especially among minorities. In the Sub-Sahara region women are disproportionately impacted by HIV/AIDS. In the fight against the spread of AIDS, the medical profession, as well as governmental and health organizations, have strongly advocated the use condoms to combat the transmission of HIV.
Condoms are the only devices available now that provide triple protection against HIV, sexually transmitted infections (STIs) and pregnancy. Further, condoms are inexpensive, and have few side effects. However, while familiarity with condoms is high among most population groups and regions, condom usage, access, and availability around the world are currently inadequate.
Condom usage is inadequate due to basic shortcomings of conventional condoms. Conventionally, condoms are of the common thin rolled variety, typically made of a thin, soft, flaccid material such as latex or polyurethane, or some type of animal intestine. The condom is typically made quite thin in order to provide acceptable tactile stimulation to transfer through the material for the active male user. However, because the condom is made as thin as possible to enhance transferred stimulation, it is susceptible to breakage, thereby exposing the user and the user's partner to sexually transmitted diseases or the risk of unplanned pregnancy. Studies have shown that commercial thin membrane latex male condoms can have a failure rate up to 18%. As such, thin rolled condoms have had an extensive history of consumer complaints regarding their effectiveness in preventing STIs and pregnancy.
Thin rolled condoms have also had an extensive history of consumer dissatisfaction regarding their diminishment of pleasure. It is well known that the use of thin rolled condoms disrupt intimacy; they can pinch and snag the skin, desensitize the sexual experience and generally interfere with the overall pleasure associated with sex. But most importantly, thin rolled condoms diminish pleasure because they overlook the ‘fluid factor’. Heterosexual contact normally occurs in the wet, slippery, warm, environment of the vagina that stimulates the orgasmic response between partners. Thin rolled condoms do not permit direct or wet contact between partners to stimulate the orgasmic response.
Thin condoms conventionally come in male and female varieties.
A male condom is of the type worn on the penis by the active male partner during sexual intercourse. The traditional male condom has an elongated tubular sheath, which is open at one end for insertion of the penis, and closed at the other end to trap ejaculate of seminal fluids. A conventional male condom is donned by unrolling and stretching the sheath onto the erect penis fitting snuggly, end to end. In most varieties, the open end generally has a peripheral bead that functions as a constricted rim to prevent the condom from slipping off during use.
Generally, the male condom is elastically fitted to cling to the penis tip, and during coitus it remains outstretched and taut, which can increase the hazard of the condom being torn or bursting during use. The structural integrity of the thin condom can also be compromised by leakage, slippage and viral penetration. Hence, male condoms are well known to be only partially effective in the prevention of sexually transmitted diseases, such as HIV. The CDC evaluates male condom effectiveness at a failure rate of up to 18%, when used correctly and consistently.
Not only do traditional male condoms have an unacceptably high risk of failure, such condoms also suffer from a number of other shortcomings that can discourage their use entirely, thus diminishing their effectiveness in the fight against the spread of AIDS. One drawback is that the use of a condom can interrupt sexual intimacy because the condom has to be donned onto the erect penis after arousal. Another drawback is that after sexual intercourse is completed, the condom may slip off as the erect penis softens, which may cause unwanted leakage of semen and/or contamination.
Yet another disadvantage of the traditional thin male condom is the loss of sensation experienced by the active male caused by the fact that the condom must be tight-fitting in order to stay in place. The conventional condom does not permit adequate sensitivity for the active male during sexual intercourse because it constricts sensation and ignores the fluid anatomy conditional to sexual intercourse. Also, because the rolled condom is fitted to move along clinging to the penis, it prevents direct fluid communication and tactile friction between the penis of the active partner and the vaginal or rectal wall of the passive partner during sexual intercourse.
Not least, most traditional male condoms are typically constructed in a single, standard size, which does not accommodate penises of different sizes in length and girth. Such construction can be uncomfortable for the male wearer when the standard size will not fit.
In addition to male condoms, there are also female condoms, which are barrier devices made to be worn internally by the female partner. The conventional female condom is typically comprised of a thin, pouch liner with a closed end and a large open end that is generally provided with a stiff outer ring, attached to hold the mouth of the liner open outside of the vagina and another inside, loose ring to position the closed end at the cervix.
One of the many disadvantages of a female (i.e. receptive) condom is that there is a risk that the condom can slip or become dislodged during sexual intercourse. For a female condom to be an effective barrier to pregnancy and/or the transmission of sexual diseases, it is essential that, even during repeated and rigorous coitus, the penis does not penetrate the vagina outside the condom (side entry).
Moreover, like most commercial male condoms, female condoms are commonly formed of latex, polyurethane, or nitrile. Because they are made of thin material, such condoms are flaccid and thus susceptible to irregular bunching during use, resulting in discomfort or generally poor performance. Moreover, such female condoms perform poorly, since their flaccid membranes do not have sufficient structural rigidity to maintain traction between the condom and the female vaginal cavity, which also could result in a risk of the penis penetrating the vagina outside the condom. Also, female condoms evaluated for efficacy by the CDC have up to a 21% failure rate when used correctly and consistently.